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Excelsior SL-10 Microcatheter, Models 168581, 168381, 168181, 168189

by Boston Scientific, Target

510(k) K013789

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK013789 Date6 Dec 2001ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-0498-2014 FDA Class II initiated 4 Nov 2013

    Products were shipped labeled with "use by" dates that exceed currently available shelf-life data. All products remain within the earliest expiration date of April 2015.

    • Terminated Z-0627-2009 FDA Unclassified (pre-2012) initiated 7 Oct 2008

    Packaging issue may result in failure to maintain sterile barrier.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DQY
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 870.1250
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Excelsior SL-10 Microcatheter is a percutaneous catheter device classified under product code DQY and regulation 870.1250. It is designed for use in cardiovascular procedures and is substantially equivalent to the Tracker-10 Microcatheter and Excelsior 1018 Microcatheter as determined through FDA 510(k) clearance.

The device was cleared via the FDA 510(k) pathway on December 6, 2001, under K013789, with a decision date of 2001-12-06 and date received of 2001-11-14. It is manufactured by Boston Scientific, Target and supplied in the models specified: 168581, 168381, 168181, and 168189. No information regarding sterility, single-use or reusable status, MRI safety, storage conditions, or clinical indications is provided in the data.

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Questions

AI-generated answers, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Excelsior SL-10 Microcatheter used for?

    The Excelsior SL-10 Microcatheter is designed for use in cardiovascular procedures as a percutaneous catheter device, based on its classification under product code DQY and regulation 870.1250, and its substantial equivalence to the Tracker-10 and Excelsior 1018 Microcatheters.

  • How is the Excelsior SL-10 Microcatheter supplied and what models are available?

    The device is supplied in four specific models: 168581, 168381, 168181, and 168189, as manufactured by Boston Scientific, Target, with no further details on packaging or configuration provided in the data.

  • Is the Excelsior SL-10 Microcatheter sterile or single-use?

    The provided data does not include information about sterility, single-use, or reusable status for the Excelsior SL-10 Microcatheter, so these details cannot be confirmed from the available specifications.

  • What regulatory pathway was used for the Excelsior SL-10 Microcatheter?

    The Excelsior SL-10 Microcatheter was cleared via the FDA 510(k) pathway under K013789, with a decision date of December 6, 2001, and a receipt date of November 14, 2001, as stated in the authorization and specifications fields.